--- title: 'Associate Director, Statistical Programming at Kardigan' canonical: 'https://feeny.ai/job/associate-director-statistical-programming-kardigan-south-san-francisco-7xw1bmv9yx1t' type: 'job' last_seen: '2026-11-07' --- # Associate Director, Statistical Programming at Kardigan - **Company:** Kardigan - **Location:** South San Francisco California United States Princeton New Jersey, United States - **Compensation:** $183k–$250k - **Posted:** 2026-11-02 - **Last confirmed live:** 2026-11-07 - **Apply:** https://job-boards.greenhouse.io/kardigan/jobs/5467290008 ## Job description ## About Us Kardigan is a heart health company working to make cardiovascular disease preventable, curable and no longer the leading cause of death in the world. It is Kardigan’s mission to develop multiple targeted treatments in parallel that bring people with cardiovascular diseases to the cures they deserve. Led by Tassos Gianakakos, Jay Edelberg, M.D., Ph.D., and Bob McDowell, Ph.D., Kardigan’s co-founders have reunited after leading MyoKardia to discover and develop mavacamten, the first cardiac myosin inhibitor, resulting in an acquisition by Bristol Myers Squibb in 2020. We have a cutting-edge discovery and translational research platform, a pipeline of late-stage candidates, and an industry-leading team that is driven to improve the lives of patients. At Kardigan, we are motivated by our values which guide how we work, interact, and achieve our goals. Driven by patients and their families, we are deeply committed to improving the lives of patients and prioritizing their needs above all else. We believe in being authentic—leading with truth to bring out the best in others by creating an environment where every person knows they will be fully accepted. With an eagerness to learn, we encourage the highest levels of curiosity and are open to changing our minds. We are committed to winning as a team with urgency, excellence, and intention, and support each other no matter what role we play or where we sit. Lastly, we strive to enable the impossible because patients are counting on us. We are not afraid to take risks to unlock innovation and advance scientific discoveries. These values are the foundation of our work, empowering us to make a real difference, every day. Department: Clinical Data Sciences & Analytics Reports To: Head of Statistical Programming Location: South San Francisco, CA or  Princeton, NJ – On-site 4 days per week (Mon to Thurs) Job Overview: The Associate Director of Statistical Programming will serve as the compound lead, responsible for programming strategy and delivery across all studies and integrated analyses for an assigned compound. This role will lead internal and outsourced programming activities, ensuring quality, consistency, and timely delivery of clinical reporting and regulatory submission deliverables, while remaining hands-on in SAS/R programming and technical review. This position will serve as the primary Statistical Programming representative on compound teams, partnering with Biostatistics and Clinical Data Management (CDM) to align data collection, analysis requirements, and programming plans. The compound lead will establish consistent programming standards across studies, coordinate resources and timelines, and proactively address delivery risks. Additionally, this position will contribute to establishing SOPs and programming standards and modernizing statistical reporting with open-source tools. ## ESSENTIAL DUTIES AND RESPONSIBILITIES Key Project Responsibilities: - Serve as the compound programming lead, accountable for study- and compound-level programming deliverables in collaboration with the lead biostatistician and cross-functional teams. - Develop and maintain programming plans, coordinate timelines and resource needs across studies, and proactively address delivery risks, escalating resource constraints and unresolved issues to the Head of Statistical Programming. - Lead programming review of SAPs, Data Presentation Plans, and Table Shells across the compound to align with development objectives and ensure clarity, consistency, and completeness of programming assumptions and requirements. - Lead the programming team to produce and/or validate SDTM, ADaM, and TLF deliverables across studies and integrated analyses for CSRs, regulatory requests, publication needs, and ad hoc analyses, remaining hands-on for complex programming and technical review. - Manage CROs and contractors supporting the compound, defining scope and acceptance criteria and ensuring compliance, quality of deliverables, and timelines. - Collaborate with biostatisticians and clinical development colleagues to develop/review TLF shells, SDTM, and ADaM specifications, establishing consistent data standards and derivation conventions across studies to support compound-level analyses. - Work closely with Data Management and Biostatistics teams to ensure database-lock readiness and the accuracy and traceability of final datasets, analyses, and reports across the compound. - Develop company tools, such as R packages, macros, and interactive data dashboards (e.g., with Shiny), to enhance the efficiency and capacity of the Statistical Programming team. - Oversee the development and validation of define.xml and supporting reviewer guides. Lead preparation of the compound’s programming deliverables for NDA eSubmissions, including integrated analyses, and coordinate programming support for responses to regulatory questions. Initiative Responsibilities: - Partner with the Head of Statistical Programming to lead initiatives that implement innovative strategies and technologies to enhance programming processes, driving adoption across the compound studies. - Contribute to establishing departmental Statistical Programming standards and SOPs, and lead implementation of programming strategies, specifications, and standardized analyses across studies within the assigned compound. - Proactively identify gaps and risks in programming capabilities and processes, lead improvement plans, and share lessons learned and best practices across the Statistical Programming team. Basic Qualifications: - Master’s degree in Statistics/Biostatistics, Mathematics, Computer Science, or a related field. - Advanced SAS and R programming skills, with experience using Git for version control required. Extensive hands-on experience with SDTM, ADaM, and TLF programming. - In-depth knowledge of CDISC standards (SDTM, ADaM) and regulatory submission requirements, with hands-on experience applying these standards and leading programming deliverables for regulatory submissions. - Strong knowledge of the drug development process, study design, statistical methodology, regulatory guidance, statistical concepts, and medical terminology, with the ability to translate analysis plans into programming requirements. - Excellent communication and collaboration skills, with the ability to represent Statistical Programming on cross-functional compound teams, influence decisions, and communicate technical risks and recommendations clearly. - Practical experience with data validation, define.xml generation, and tools such as Pinnacle 21, including preparation and review of supporting reviewer guides and resolution or documentation of conformance findings. - Experience managing outsourced programming activities and overseeing CROs and contractors, including defining scope and quality expectations, monitoring timelines and budgets, and resolving delivery issues. - Demonstrated ability to provide technical leadership and mentoring to study programmers and lead a programming team while remaining hands-on in programming and technical review. Preferred Qualifications: - 8+ years of statistical programming experience in the pharmaceutical, biotech, or CRO clinical trial environment, including demonstrated experience leading programming across multiple studies within a compound or development program preferred. - Broad expertise in statistical programming and developing compound-level programming strategies, including cross-study standards, resource planning, timeline management, and risk mitigation. - Experience with regulatory audits and inspections (e.g., FDA, PMDA, NMPA, EMA) is a strong advantage. Exact Compensation may vary based on skills, experience and location. Pay range $183,000—$250,000 USD ## About Kardigan ## Company Overview - **One-liner**: Kardigan is a publicly traded biopharmaceutical company developing targeted cardiovascular therapies with the aim of transforming treatment from symptom management toward functional cures. - **Entity Type**: Public (ticker not available from provided sources; IPO closed as per company announcement) - **Headquarters**: South San Francisco, California, United States (with additional offices in Princeton, New Jersey and Chicago, Illinois) - **Founded**: Year not specified in available sources - **Founders**: Tassos Gianakakos (Co-Founder, CEO & Chair), Dr. Jay Edelberg (Co-Founder & Chief Medical Officer), Dr. Bob McDowell (Co-Founder & Scientific Adviser), Brianne Puglisi (Co-Founder) ## Core Business - **Primary industry**: Biopharmaceuticals – cardiovascular drug discovery and development - **Target customers**: B2B / B2G – healthcare providers, hospitals, payers, and patients; the company develops prescription medicines for serious cardiovascular conditions - **Mission or purpose statement**: “To make cardiovascular disease preventable, curable and no longer the leading cause of death in the world.” ([kardigan.bio](https://www.kardigan.bio/)) ## Products & Services - **Tonlamarsen**: A Phase 2/3 candidate for acute severe hypertension (ASH) and uncontrolled hypertension. Positive Phase 2 data presented as a late-breaker at ACC.26 and simultaneously published in JACC. ([kardigan.bio](https://www.kardigan.bio/)) - **Danicamtiv**: A Phase 3 candidate for genetic dilated cardiomyopathy (DCM), targeting the underlying inherited cardiac muscle disease. ([kardigan.bio](https://www.kardigan.bio/)) - **Calcific Aortic Valve Stenosis (CAVS) Program**: A late-stage clinical program addressing calcium deposition that stiffens the aortic valve. ([kardigan.bio](https://www.kardigan.bio/)) - **Prolaio Subsidiary**: An AI and real‑world data platform integrated into Kardigan to generate insights, inform clinical trial design, and reduce time/cost of drug development. ([kardigan.bio](https://www.kardigan.bio/about-us/)) - **Cardiac Intelligence Platform**: A discovery and translational research engine that uses real‑world patient data, AI, and deep cardiovascular expertise to identify disease drivers and design targeted therapies. ([kardigan.bio](https://www.kardigan.bio/)) ## Market Standing - **Valuation/Market Cap**: Not disclosed in provided sources - **Key Metric**: Public company (IPO closed); annual revenue not disclosed - **Notable Investors/Partners**: Not explicitly listed in provided sources; company built on the team’s track record from MyoKardia (acquired by Bristol Myers Squibb for $13.1B in 2020) - **Growth Signals**: - Positive Phase 2 pivotal data for Tonlamarsen in hypertension, presented at ACC.26 and published in JACC - Three late‑stage clinical programs (CAVS, ASH, DCM) running in parallel - Active job postings across 210+ roles in clinical operations, data science, manufacturing, and corporate strategy, indicating scaling ([job-boards.greenhouse.io/kardigan](http://job-boards.greenhouse.io/kardigan)) - Integration of Prolaio’s AI platform to accelerate R&D ## Competitive Advantages - **Leadership expertise**: CEO Tassos Gianakakos previously scaled MyoKardia from startup to a $13.1B acquisition; the team includes veterans from MyoKardia, Sanofi, BMS, and Merck. - **Parallel pipeline strategy**: Multiple late‑stage programs targeting distinct cardiovascular diseases (valve, hypertension, cardiomyopathy) de‑risks development and creates data synergies. - **Cardiac Intelligence platform**: Proprietary combination of real‑world data, AI, and deep biological insight to move beyond symptom management toward modifying underlying disease. - **Focus on functional cures**: Each program aims to alter the course of disease rather than merely treat symptoms, creating potential for breakthrough efficacy. ## Strategic Focus - **Advance late‑stage clinical trials**: Continue Phase 2/3 studies for Tonlamarsen, Danicamtiv, and CAVS while preparing for potential regulatory submissions. - **Expand platform capabilities**: Leverage Prolaio’s AI and real‑world evidence to design smarter, faster trials and discover new drug targets. - **Build commercial infrastructure**: Growing corporate strategy, medical affairs, and manufacturing teams in South San Francisco, Princeton, and Chicago signals preparation for launch. ## Why Work Here - **Culture**: “Everything we do starts with patients – and it’s powered by people.” Emphasis on collaboration, purpose‑driven work, and achieving the impossible together. Mission‑oriented environment focused on curing cardiovascular disease. ([kardigan.bio](https://www.kardigan.bio/job-openings/)) - **Work model**: Roles are listed for South San Francisco, Princeton, NJ, and Chicago, IL; likely on‑site/hybrid given the lab and clinical development nature. Not purely remote. - **Benefits**: - Competitive salaries and annual bonus program - Comprehensive medical, dental, and vision coverage - 401(k) plan, life and disability insurance - Flexible spending and health savings accounts - Commuter benefits, cellphone allowance - Paid holidays and time off - Employee assistance program ([kardigan.bio](https://www.kardigan.bio/job-openings/)) - **Engineering & data science culture**: Active recruitment for data analytics, AI, and clinical data science roles; Executive Director of Data, AI & Collaboration Services is an open position, reflecting a strong tech‑driven R&D approach. ## Sources 1. [kardigan.bio](https://www.kardigan.bio/) – Company homepage and pipeline descriptions 2. [kardigan.bio/about-us](https://www.kardigan.bio/about-us/) – About Us, mission, and Prolaio integration 3. [kardigan.bio/job-openings](https://www.kardigan.bio/job-openings/) – Careers page with benefits and open roles 4. [kardigan.bio/leadership](https://www.kardigan.bio/leadership/) – Leadership team and co‑founder backgrounds 5. [job-boards.greenhouse.io/kardigan](http://job-boards.greenhouse.io/kardigan) – Detailed job listings (32+ postings) ## Other roles at Kardigan - [Senior Director, Development Operations & Biometrics, Strategy & Operational Excellence.](https://feeny.ai/job/senior-director-development-operations-biometrics-strategy-operational-0n6vyrnendej) — Princeton, NJ - [Associate Director / Director, Data & AI Solution Development](https://feeny.ai/job/associate-director-director-data-ai-solution-development-kardigan-princeton-dhedxxdyxbxv) — Princeton, NJ - [Senior Director, Head of GxP Compliance](https://feeny.ai/job/senior-director-head-of-gxp-compliance-kardigan-south-san-francisco-california-cc61pvwbwven) — South San Francisco California United States Princeton New Jersey, United States - [Sr. Director, Vendor & Relationship Management](https://feeny.ai/job/sr-director-vendor-relationship-management-kardigan-princeton-c6jea5671m8f) — Princeton, NJ - [Director, Investor Relations](https://feeny.ai/job/director-investor-relations-kardigan-princeton-1kmgtsmky5wf) — Princeton, NJ - [Vice President, Global Program Head](https://feeny.ai/job/vice-president-global-program-head-kardigan-princeton-z22c8nxn2356) — Princeton, NJ - [Director, Pharmacovigilance Scientist](https://feeny.ai/job/director-pharmacovigilance-scientist-kardigan-princeton-xy7mfpv2kgmm) — Princeton, NJ - [Contracts Manager (Prolaio)](https://feeny.ai/job/contracts-manager-prolaio-kardigan-chicago-42r8rkrddx72) — Chicago, IL - [Executive Director, Global Program Manager](https://feeny.ai/job/executive-director-global-program-manager-kardigan-princeton-22n8a9rqn2kb) — Princeton, NJ - [Director, Clinical Quality Lead](https://feeny.ai/job/director-clinical-quality-lead-kardigan-south-san-francisco-california-united-qzg2emd2he5j) — South San Francisco California United States Princeton New Jersey, United States